FDA 510(k) Application Details - K093291

Device Classification Name System, Applicator, Radionuclide, Remote-Controlled

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510(K) Number K093291
Device Name System, Applicator, Radionuclide, Remote-Controlled
Applicant VARIAN MEDICAL SYSTEMS, INC.
3100 HANSEN WAY
PALO ALTO, CA 94304 US
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Contact VY TRAN
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Regulation Number 892.5700

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Classification Product Code JAQ
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Date Received 10/21/2009
Decision Date 11/17/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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